FLAGYL FC 200 TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Sanofi-Aventis South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS METRONIDAZOLE 200 mg

Authorization status:

Canceled

Authorization date:

1994-10-03

Patient Information leaflet

1
SCHEDULING STATUS:
S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
FLAGYL 200 (Tablets)
FLAGYL 400 (Tablets)
FLAGYL SUSPENSION (200 mg/5 ml)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
TAKING FLAGYL:

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or your
pharmacist.

FLAGYL has been prescribed for you personally and you should not share
your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
WHAT FLAGYL CONTAINS:
The active substance is metronidazole.
FLAGYL 200
Each tablet contains:
Metronidazole 200 mg
Preservative:
Methyl hydroxybenzoate 0,1 % _m/m _
OTHER INGREDIENTS ARE:
Maize starch, calcium carbonate, methyl hydroxybenzoate, sodium lauryl
sulphate, stearic acid
and microcrystalline cellulose.
FLAGYL 400
Each tablet contains:
Metronidazole 400 mg
2
Preservative:
Methyl hydroxybenzoate 0,1 % _m/m_
Contains tartrazine.
OTHER INGREDIENTS ARE:
Methyl hydroxybenzoate, maize starch, calcium carbonate,
microcrystalline cellulose, potassium
dihydrogen phosphate, sodium hydroxide, sodium lauryl sulphate,
stearic acid and yellow dye
(CI 19140).
FLAGYL SUSPENSION
Each 5 ml contains:
Benzoyl metronidazole equivalent to metronidazole 200 mg
Preservatives:
Methyl hydroxybenzoate 0,08 % _m/v_
Propyl hydroxybenzoate 0,02 % _m/v _
Contains sugar (sucrose).
OTHER INGREDIENTS ARE:
Sodium dihydrogen phosphate, methyl hydroxybenzoate, propyl
hydroxybenzoate, ethanol,
sucrose, veegum h.v., lemon flavouring, oil of orange and water.
WHAT FLAGYL IS USED FOR:
FLAGYL contains metronidazole, and it works by killing bacteria and
parasites that cause
infections in your body.
IT CAN BE USED TO:

Treat infections caused by certain bacteria

Prevent infections after surgery.
If you or your child need any further information on your illness,
speak to your doctor.
3
BEFORE YOU TAKE FLAGYL:
DO NOT TAKE FLAGYL IF:

You or your child are allergic (hypersensitive) to metronidazole or
any of the

Summary of Product characteristics

1
SCHEDULING STATUS: S4
PROPRIETARY NAME (AND DOSAGE FORM):
FLAGYL 200 (Tablets)
FLAGYL 400 (Tablets)
FLAGYL SUSPENSION
COMPOSITION:
FLAGYL 200
Each tablet contains:
Metronidazole
200 mg
Preservative:
Methyl hydroxybenzoate
0,1 % _m/m_
EXCIPIENTS:
Maize starch, calcium carbonate, methyl hydroxybenzoate, sodium lauryl
sulphate, stearic acid
and microcrystalline cellulose.
FLAGYL 400
Each tablet contains:
Metronidazole
400 mg
Preservative:
Methyl hydroxybenzoate
0,1 % _m/m_
Contains tartrazine.
EXCIPIENTS:
Methyl hydroxybenzoate, maize starch, calcium carbonate,
microcrystalline cellulose, potassium
dihydrogen phosphate, sodium hydroxide, sodium lauryl sulphate,
stearic acid and yellow dye
(CI 19140).
2
FLAGYL SUSPENSION
Each 5 ml contains:
Benzoyl metronidazole equivalent to metronidazole
200 mg
Preservatives:
Methyl hydroxybenzoate
0,08 % _m/v_
Propyl hydroxybenzoate
0,02 % _m/v _
Contains sugar (sucrose).
EXCIPIENTS:
Sodium dihydrogen phosphate, methyl hydroxybenzoate, propyl
hydroxybenzoate, ethanol,
sucrose, veegum h.v., lemon flavouring, oil of orange and water.
PHARMACOLOGICAL CLASSIFICATION:
A 20.2.6 Antimicrobial (chemotherapeutic) agents: Medicines against
protozoa
PHARMACOLOGICAL ACTION:
PHARMACODYNAMIC PROPERTIES:
Metronidazole has antiprotozoal activity against _Trichomonas
vaginalis_ and other protozoa,
including _Entamoeba histolytica_ and _Giardia lamblia_. It does not
affect the acidophilic flora of
the vagina and it has no effect on Candida species. Metronidazole has
bactericidal activity
against obligate anaerobic bacteria, whether they are Gram-positive or
-negative and bacilli or
cocci. It has no antibacterial activity against aerobic and
facultative anaerobic bacteria.
Metronidazole does not interfere with the activity of antibacterial
agents which are active against
a variety of aerobes and facultative anaerobes.
The following has been proposed as the mode of action of
metronidazole: The parent
compound penetrates the cell membrane unchanged, but once inside the
cell the nitro group
is reduce